Medicament dispenser

ABSTRACT

An injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, antibiotics, oncolytics and the like from a prefilled container at a uniform rate. The dispenser includes a unique stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from the prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.

BACKGROUND OF THE INVENTION

This is a Divisional application of application Ser. No. 08/473,650filed Jun. 6, 1995, now U.S. Pat. No. 5,743,879, which is aContinuation-In-Part of application Ser. No. 08/349,496 filed Dec. 2,1994, now abandoned.

FIELD OF THE INVENTION

The present invention relates generally to fluid medicament dispensers.More particularly, the invention concerns a dispenser for use incontrollably dispensing a liquid medicament as, for example, an insulinsolution.

DISCUSSION OF THE INVENTION

Traditionally, conventional syringes are used to inject many beneficialagent solutions such as insulin. In accordance with conventionalprocedures, the prescribed dose is first drawn into the syringe and avisual check is made to make certain that the correct amount of insulinis present in the syringe. Next, air is expelled from the syringe andthe dose is injected manually.

These conventional procedures have numerous drawbacks including adversereaction caused by the bolus injection of drugs by hand via a syringe.In the majority of cases, the adverse reactions are not due to the drugitself, but rather are due to an improper rate of injection of the drug.Ideally, the contents of a syringe should be delivered over a number ofminutes or hours. However, in clinical practice, this rarely occurs dueto time pressure on the staff who must operate the syringe manually.

Because diabetics generally require regular and repeated injections ofinsulin, the use of self-delivering devices, such as conventionalsyringes, is cumbersome, time consuming, and dangerous if not properlyperformed. In addition, the process of sticking one's self and expulsingthe liquid medicament can be extremely unpleasant for the medicallyuntrained. For this reason, several types of dispensing devices havebeen suggested for automatically dispensing a predetermined quantity ofa liquid medicament such as insulin from a multi-does container.Exemplary of such devices are those described in European PatentApplication No. 37696 and in U.S. Pat. No. 4,592,745 issued to Rex, etal. Both of the aforementioned devices dispense a predetermined quantityof liquid from a liquid reservoir or container and both includemechanical operating mechanisms for expelling the fluid from thereservoir.

The Rex, et al device comprises an elongated body formed from twoseparable sections one of which contains an operating mechanism and theother of which contains a prefilled cartridge. The operating mechanismof the device mechanically advances an axially movable piston rod which,in turn, drives a piston plug located inside the cartridge so as toexpel fluid from the device via a needle located at the bottom end ofthe body. The piston rod advances in successive axial steps of fixedlength through rotation of a rotatable piston rod nut. The piston rodnut is driven by a rotatable worm, which is rotated by the advancingaxial movement of a pressure device located at the top of the elongatedbody.

The EPO application discloses a dispensing device somewhat similar tothe Rex, et al. device, but embodies an operating mechanism thatcomprises a pawl which permits relative movement of a ratchet-toothedmember in a substantially rectilinear arrangement. As in the Rex, et al.device, the operating mechanism drives the plunger of a medicament vialto expel fluid therefrom.

U.S. Pat. No. 4,813,937 issued to Vaillancourt discloses an infusionsystem in which the inflow of fluid into the device causes anelastomeric member attached to a piston to be moved so as to stretch theelastomeric member. The thusly tensioned elastomeric member provides thesource of energy to expel the fluid from the device when the outlettubing of the system is opened. However, as is clear from a study of theVaillancourt patent, the device disclosed therein operates in asubstantially different manner than the device of the present invention.

Electrically operated syringe pumps are also well known, however, theyare typically of considerable complexity and are designed to inject verysmall doses of medicine with considerable accuracy over a long period,which may be up to 24 hours. Such syringe pumps do not provide theinexpensive, simple and manually operated device suitable for the slowinjection of drugs over a shorter period of time, which may range fromone to 15 minutes.

Many of the prior art medicament dispensing devices are of complexconstruction and, therefore, are often very expensive to manufacture.Additionally, such devices tend to be somewhat unreliable in use andfrequently have a limited useful life. In using certain of the prior artdevices, maintaining sterility has also proven to be a problem.

As will be appreciated from the discussion which follows, the apparatusof the present invention uniquely overcomes the drawbacks of the priorart by providing a novel, disposable dispenser of simple but highlyreliable construction. A particularly important aspect of the apparatusof the present invention resides in the provision of a novel,self-contained energy source in the form of a constant-force spring thatprovides the force necessary to uniformly and precisely dispensesolutions, such as insulin, from standard prefilled containers that canbe conveniently loaded into the apparatus. Because of the simplicity ofconstruction of the apparatus of the invention, and the straight-forwardnature of the energy source, the apparatus can be manufactured at lowcost without in any way sacrificing accuracy and reliability.

A somewhat similar medicament dispenser is disclosed in co-pendingapplication Ser. No. 08/349,496 filed by the present inventor. Thisapplication is hereby incorporated herein by reference as though fullyset forth herein. Reference to this earlier-filed application will showthat the device of the present invention embodies a stored energy meansof quite a different construction and mode of operation than thatdisclosed in Ser. No. 08/349,496.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a small, compactfluid dispenser for use in controllably dispensing fluid medicaments,such as insulin, antibiotics, oncolytics and the like from a prefilledcontainer at a uniform rate.

Another object is to provide a device of the aforementioned characterwhich is of very simple construction and embodies a minimum number ofparts.

Another object of the invention is to provide a small, compact fluiddispenser that is receivable within a housing to which a fill vial canbe connected for filling the dispenser with the fluid.

Another object of the invention is to provide a dispenser of in which astored energy source is provided in the form of a stretchable,elastomeric member of novel construction that provides the forcenecessary to continuously and uniformly expel fluid from the prefilledcontainer.

Another object of the invention is to provide a dispenser of thecharacter described in the preceding paragraph in which the elastomericmember is uniformly and controllably stretched by a novel stretchingmechanism and, after being stretched, exhibits a tendency to predictablyreturn toward it original configuration.

Another object of the invention is to provide a dispenser of the classdescribed which includes a fluid flow control assembly that filters andprecisely controls the flow of the medicament solution from theprefilled container.

Another object of the invention is to provide a fluid dispenser which isadapted to be used with conventional prefilled insulin drug vials todeliver an insulin solution therefrom in a precise and sterile manner.

Another object of the invention is to provide a fluid dispenser of theclass described which is compact, lightweight, is easy for ambulatorypatients to use, is fully disposable, and is extremely accurate so as toenable the infusion of precise doses of insulin over prescribed periodsof time.

Another object of the invention is to provide a self-containedmedicament dispenser which is of very simple construction and yetextremely reliable in use.

Another object of the invention is to provide a dispenser of the classdescribed which includes means for interconnecting the device with thebody or clothing of the patient.

Another object of the invention is to provide a fluid dispenser asdescribed in the preceding paragraphs which is easy and inexpensive tomanufacture in large quantities.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective, exploded view of one embodiment ofthe dispensing apparatus of the present invention for dispensing fluidsat a uniform rate.

FIG. 2 is a cross-sectional, exploded view of the dispensing headportion of the apparatus of FIG. 1.

FIG. 3 is a view taken along lines 3--3 of FIG. 2.

FIG. 4 is an enlarged, side-elevational, cross-sectional view of theassembled apparatus of the form of the invention shown in FIG. 1.

FIG. 4A is an enlarged, side-elevational, cross-sectional view of theforward portion of the apparatus illustrating the appearance of thevarious components during the filling step.

FIG. 5 is an enlarged side-elevational view similar to FIG. 4, butshowing the apparatus filled with the fluid to be dispersed.

FIG. 6 is a generally perspective, exploded view of an alternateembodiment of the dispensing apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 7 is a fragmentary, cross-sectional, exploded view of the forwardportion of the apparatus including the dispensing head.

FIG. 8 is a view taken along lines 8--8 of FIG. 7.

FIG. 9 is a view of the rate control element side of fluid flow controlassembly of the apparatus.

FIG. 10 is a side-elevational, cross-sectional view of the fluid flowcontrol assembly of the apparatus.

FIG. 11 is a front view of the filter element side of the fluid flowcontrol assembly of the apparatus.

FIG. 12 is an enlarged, side-elevational view of the assembled apparatusof the form of the invention shown in FIG. 6.

FIG. 13 is an enlarged, side-elevational view similar to FIG. 12, butshowing the apparatus filled with the fluid to be dispersed.

FIG. 13A is a fragmentary, side-elevational view of the forward portionof the device as it appears during the fluid dispensing step.

FIG. 14 is a generally perspective, exploded view of still anotherembodiment of the dispensing apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 15 is a top plan, exploded view of the housing of the apparatuspartly broken away to show internal construction, and of the fluidexpelling and fluid filling subassemblies of the apparatus.

FIG. 16 is a right end view of the apparatus shown in FIG. 14.

FIG. 17 is an enlarged, generally perspective exploded view of the fluiddispensing head and flow control means of this latest form of theinvention.

FIG. 17A is a cross-sectional view taken along lines 17A--17A of FIG.16.

FIG. 18 is a generally perspective view of still another embodiment ofthe dispensing apparatus of the present invention for dispensing fluidsat a uniform rate.

FIG. 19 is a generally perspective, diagrammatic view illustrating themanner in which a portion of the operating member of the apparatus isadvanced by the user into the body of the apparatus.

FIG. 20 is a fragmentary, generally perspective view of the left-endportion of the apparatus shown in FIG. 18 illustrating rotationalmovement of the end portion and further illustrating the direction ofthe force necessary to operate the locking mechanism of the device.

FIG. 21 is a generally perspective, exploded view of the apparatus ofthe invention shown in FIG. 18.

FIG. 22 is an enlarged, left-end view of the apparatus shown in FIG. 1.

FIG. 23 is an enlarged, cross-sectional view taken along lines 23--23 ofFIG. 22.

FIG. 24 is a cross-sectional view taken along lines 24--24 of FIG. 23.

FIG. 25 is a cross-sectional view taken along lines 25--25 of FIG. 23.

FIG. 26 is a cross-sectional view taken along lines 26--26 of FIG. 23.

FIG. 27 is a cross-sectional view taken along lines 27--27 of FIG. 23.

FIG. 28 is a cross-sectional view taken along lines 28--28 of FIG. 23.

FIG. 29 is a cross-sectional view taken along lines 29--29 of FIG. 23.

FIG. 30 is a cross-sectional view taken along lines 30--30 of FIG. 23.

FIG. 31 is a cross-sectional view taken along lines 31--31 of FIG. 23.

FIG. 32 is a development view taken along lines 32--32 of FIG. 31illustrating the manner in which the locking teeth and locking tabs ofthe device cooperate to lock the operating member to the housing.

FIG. 33 is an enlarged, cross-sectional view similar to FIG. 23, butshowing the position of the component parts of the apparatus after aportion of the operating member has been threadably advanced into thebody.

FIG. 34 is a fragmentary, cross-sectional view of the dispensing endportion of the apparatus illustrating the position of the cooperatingcomponent parts after the cannula has pierced the pierceable septum ofthe medicament vial.

DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to FIGS. 1 through 5, oneembodiment of the medicament delivery system of the present invention isthere illustrated and generally designated by the numeral 12. Thisembodiment is somewhat similar to that described in the parentapplication No. 08/349,496 which is incorporated by reference. However,the forms of the invention shown herein are quite small, very compact,easy to use, and are of a less complex construction than thoseillustrated and described in the parent application.

The apparatus of this latest form of the invention comprises a container14, having a first open end 14a and a closed end 14b. End 14b is closedby an end wall 14c having a centrally disposed socket like portion 14dand a vent "V" for venting the interior of the container to atmosphere.Received within a reservoir-defining chamber 14e of container 14 is thestored energy means of this form of the invention, the purpose of whichwill presently be described.

First end 14a of the container is closed by a fill and dispensing meansfor filling chamber 14e with fluid and for dispensing fluid therefrom.The fill and dispensing means here comprises a dispensing head assemblygenerally designated by the numeral 18. As best seen in FIG. 2, assembly18 includes a closure cap 20 which is receivable over container 14 inthe manner shown in FIGS. 4 and 5. Disposed within cap 20 is a flowcontrol means for controlling the outward flow of fluid flowing from thereservoir or internal chamber 14e of container 14. The flow controlmeans of this embodiment of the invention comprises a generally annularshaped flow rate control element 24 and a generally annular shapedfilter element 26. The flow control means further includes valve meanswhich are supported within head assembly 18 by an apertured support 27which supports the laminate made up of elements 24 and 26 and a bore 20aprovided in the forward wall 20b of cap 20 (see FIG. 4). In a mannerpresently to be described, the valve means functions to block fluid flowbetween reservoir 14e and the fluid passageway 30a of a luer connector30 which extends outwardly from wall 20b of cap 20 and defines the fluidinlet 30b of the device. The valve means here comprises a valve member32 having a neck portion 32a and a seat engaging portion 32b whichsealably engages a valve seat 34 formed internally of bore 20a.

Turning to FIGS. 3 and 4A it is to be noted that bore 20a includes aplurality of circumferentially spaced bypass flow channels 35 whichpermit fluid flow into reservoir 14e when valve member 32 is movedrearwardly away from seat 34 in the manner shown in FIG. 4A. As seen inFIG. 3, cap 20 is provided with an annular collector manifold 36 havingmicro-channels 38 that direct fluid flow from reservoir 14e toward theoutlet port 40 of the device via a fluid passageway 41. Connected tooutlet port 40 is a delivery conduit 42 having at its outboard end amale luer fitting 43 which mates with a female luer cap 45.

Disposed within reservoir 14e of the container 14 is the importantstored energy means of the invention, which functions to urge fluidcontained within the reservoir outwardly of the device via the flowcontrol means. This unique stored energy means here comprises aspecially configured elastomeric spring-like member 48 which is movablefrom a first configuration shown in FIG. 4 to a second, more compressedconfiguration shown in FIG. 5 wherein it has a tendency to return towardits first configuration. As best seen in FIG. 1, member 48 comprises anelongated compressible member having a plurality of longitudinallyspaced apart grooves and ridges 48a and 48b respectively.

As discussed in U.S. Ser. No. 08/349,496, which is incorporated hereinby reference, the stored energy means can be constructed from a widevariety of materials including rubbers, plastics and other thermoplasticelastomers (TPE) and thermoplastic urethane (TPU). By way of example,suitable materials include latex rubber, rubber polyolefins,polyisoprene (natural rubber), butyl rubber, nitrile rubber,polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, otherhomopolymer, copolymers (random alternating, block, graft, cross-linkand star block), silicones and other flouropolymers, mechanicalpolyblends, polymer alloys and interpenetrating polymer networks.

In operating the apparatus of the form of the invention shown in FIGS. 1through 5, with the outlet conduit 42 closed by luer closure cap 45(FIG. 4), a suitable filling tube "FT" and luer connector "LC" (FIG. 4)is interconnected with luer fitting 30 to enable filling of reservoir14e with the fluid to be dispensed. During filling, valve member 32 willmove away from seat 34 and into engagement with a central wall portion27a provided on support 27 (FIG. 2) thereby permitting fluid to flowfrom the fill tube past valve member 35 via bypass channels 33 and intoreservoir 14e.

As the fluid under pressure flow through bypass channels 35, and intoreservoir 14e, it will engage the forward piston-like portion 48c of thestored energy member 48 urging portion 48c inwardly of reservoir 14e. Asthe fluid under pressure urges piston portion 48a telescopically of thereservoir, the body portion of the stored energy member will becompressed in the manner indicated in FIG. 5. When fluid flow ceasesthrough fill tube 52, check valve member 32 will be urged by the fluidpressure within reservoir 14e into seating engagement with valve seats34 thereby sealing the inlet port of the device so that the fluid "F"which is to be dispensed will be contained within reservoir 14e.

Following the filling step, a closure plug assembly "CP" is connectedwith luer fitting 30 so as to sealably close inlet 30b. As best seen inFIG. 1, closure plug assembly "CP" comprises a cap 50 which includes amultiplicity of circumferentially spaced locking fins 50a which arelockably received within a multiplicity of circumferentially spacedlocking tabs 51 provided on assembly 18 (FIG. 1). With thisconstruction, following filling, cap assembly "CP" is locked to assembly18.

Upon opening the fluid delivery path by removal of closure cap 45 (FIG.4), the stored energy means, or member 48, will tend to return to itsuncompressed starting configuration thereby controllably urging fluidflow outwardly of the device via apertures 27b in support 27, via ratecontrol element 24 and via filter element 26. Fluid flowing throughthese elements will flow into annular shaped fluid collection passageway36 and then outwardly of the device via the delivery tube 42. Filter 26which functions to filter particulate matter from the fluid flowingoutwardly from reservoir 14e is of a character well known to thoseskilled in the art and can be constructed from various readily availablematerials such as polysolfone and polypropylene wafers having a desiredporosity. Similarly, rate control element 24 can be constructed from anysuitable porous material such as polycarbonate, a metal or a ceramichaving the desired porosity.

As before various fluids can be dispensed from container 14, including,by way of example, beneficial agents such as medicaments of varioustypes, drugs, pharmaceuticals, hormones, antibodies, biologically activematerials, elements, chemical compounds, or any other suitable materialuseful in diagnostic cure, medication, treatment or preventing ofdiseases or the maintenance of the good health of the patient.

Turning next to FIGS. 6 through 13 of the drawings, still another formof the dispensing apparatus of the present invention is thereillustrated and generally designated by the numeral 60. The apparatus ofthis alternate form of the invention is also similar in certain respectsto the previously described embodiments of the invention.

The apparatus of this latest form of the invention, like the embodimentjust described, comprises a container 62, having a first open end 62aand a closed end 62b and a fluid reservoir 62c disposed between ends 62aand 62b. End 62b is closed by an end wall 62d provided with a gas vent63 for venting any gases contained within reservoir 62c to atmosphere.Vent 63 can be constructed of a suitable porous material such as aporous plastic. Received within reservoir 62c is the stored energy meansof this form of the invention, the character of which will presently bedescribed.

First end 62a of the container is closed by a fill and dispensing meansshown here as a head assembly generally designated by the numeral 64. Asbest seen in FIG. 7, head assembly 64 is of a slightly differentconstruction than the previously described fill and dispensing head andincludes a closure cap 66 which is receivable over end 62a of container62 in the manner shown in FIG. 12. Disposed within cap 66 is a flowcontrol means for controlling the outward flow of fluid flowing from thereservoir or internal chamber 62c of container 62. The flow controlmeans of this embodiment of the invention comprises a generally annularshaped flow rate control element 67 and a generally annular shapedfilter element 68. The flow control means further includes a supportmember 70 which is disposed between, and provides support to, ratecontrol element 67 and filter element 68. As shown in FIG. 10, supportmember 70 is provided with a plurality of circumferentially spaced fluidflow passageways 70a.

Cap 66 is provided with an annular shaped fluid collection channel 72which is in communication with passageway 70a and also with the outletport 73 of the device. Connected to cap 66 proximate outlet port 73 is ahollow infusion needle 74 which is protectively surrounded by anintegrally molded twist off cap 75 and a closely fitting closure sleeve77, which cooperate to maintain the needle in a sterile condition andprevent fluid flow until time of use.

Disposed within chamber 62c of the container is the important storedenergy means of the invention, which functions to urge fluid containedwithin reservoir 62c outwardly of the device via the flow control meansand infusion needle 74. This unique stored energy means here comprises aspecially configured sponge like member 78 which is movable from a firstconfiguration shown in FIG. 12 to a second, more compressedconfiguration shown in FIG. 13 wherein it has a tendency to returntoward its first configuration.

As previously discussed, the stored energy means, including the storedenergy means of this latest embodiment of the invention, can beconstructed from a wide variety of materials including rubbers, plasticsand other thermoplastic elastomers (TPE) and thermoplastic urethane(TPU).

In operating the apparatus of the form of the invention shown in FIGS. 6through 13, with the fluid passageway of needle 74 closed by closuresleeve 77, reservoir 62c is filled with the fluid to be dispensed usinga syringe having a needle adapted to penetrate a centrally disposed,penetrable septum 80 which is mounted within a central bore 66a providedin cap 66.

As the fluid under pressure flowing from the filling syringe (not shown)enters reservoir 62c, it will engage a piston-like member 82 which istelescopically movable longitudinally of reservoir 62c. This fluid underpressure will urge member 82 telescopically inward of the reservoircausing the stored energy member to be compressed in the mannerindicated in FIG. 13.

Upon removing twist off cap 75 and closure sleeve 77 from the needlethereby opening the fluid delivery path of the device, stored energymember 78 will tend to return to its uncompressed, startingconfiguration thereby controllably urging fluid flow outwardly ofreservoir 62c via filter element 68 and rate control element 67. Fluidflowing through these elements will next flow into annular shaped fluidpassageway 72 and then outwardly of the device through infusion needle74. Filter 68 which functions to filter particulate matter from thefluid flowing outwardly from reservoir 62c is of the characterpreviously described herein as is rate control element 67. As before,the various fluids previously identified herein can be dispensed fromreservoir 62c. During the delivery step, the infusion needle is, ofcourse, inserted into the vein of the patient. To stabilize the device,cap assembly 64 includes a curved base portion 64a which can be affixedto the patient by an adhesive layer 64b which is protected prior to useby a peal strip 64c (FIG. 13A).

Turning now to FIGS. 14 through 17A, yet another embodiment of theinvention is there shown. The dispensing means of this embodiment issomewhat similar to that shown in FIGS. 1 through 5, but the fill meansof the apparatus is quite different. More particularly, the fill meanshere comprises a separate fill assembly 81 (FIG. 15), which isinsertable into a chamber formed in a housing 83 of novel construction.As best seen in FIGS. 14 and 15, housing 83 includes a base portion 83aand an upper body portion cover 83b having first and secondlongitudinally extending internal chambers 83c and 83d which aresuitably vented to atmosphere by vents "V". Formed within chamber 83c isa fluid reservoir 84 having a first open end 84a and a closed second end84b (FIG. 17A). First end 84a is closed by a closure cap assembly 86 ofthe character shown in FIGS. 14, 15, and 17, which assembly comprises apart of the dispensing means of this embodiment of the invention.

Cap assembly 86 includes a hollow cap 87 which carries the flow controlmeans of this form of the invention for controlling the flow of fluidoutwardly of reservoir 84. The flow control means here comprises agenerally disc shaped flow rate control wafer 88 and a generally discshaped filter wafer 89 which are supported in a back-to-backrelationship by an apertured support member 90. As shown in FIG. 17,member 90 is provided with a plurality of circumferentially spaced flowpassageways 90a to permit fluid flow toward the laminate assemblage madeup of wafers 88 and 89.

In this latest form of the invention, cap 87 includes a plurality ofradially extending support ribs 87a for supporting the flow controlmeans. Cap 87 also includes a centrally disposed outlet, or fluiddelivery port 92, to which a suitable delivery tube (not shown) can beconnected (FIG. 17). The flow control means here operates in the samemanner to accomplish the same result as does the flow control meansconsidered in connection with the earlier described embodiments of theinvention.

Disposed within reservoir 84 is the important stored energy means of theinvention, which functions to urge fluid contained within the reservoiroutwardly of the device via the flow control means and delivery port 92.This unique stored energy means here comprises a specially configuredelastomeric spring-like member 94 which is movable from a first expandedconfiguration shown in FIG. 15 to a second, more compressedconfiguration shown in FIG. 17A wherein it has a tendency to returntoward its first configuration. As best seen in FIG. 15, member 94comprises an elongated body having a plurality of longitudinally spacedapart grooves and ridges 94a and 94b respectively. Once again, thestored energy means can be constructed from a wide variety of materialsincluding rubbers, plastics and other thermoplastic elastomers (TPE) andthermoplastic urethane (TPU). The forward end 94c of member 94 engages apiston-like member 95 which is telescopically movable within chamber 83cof body 83.

Receivable within the second longitudinally extending chamber 83d ofhousing 83 is the previously mentioned fill means of the invention. Thisnovel fill means includes fill vial assembly 81 which comprises a fillvial 99 having a first open end 99a and a second closed end 99b. Fillvial 99 also includes fluid reservoir 99c within which a plunger-likemember 100 is telescopically movable from a first position to a secondposition. Plunger 100, which is constructed of a non-coring elastomer,is adapted to be pierced by an elongated hollow needle 102 which extendslongitudinally of chamber 83d of housing 83 in the manner shown in FIG.17A.

In operating the apparatus of the form of the invention shown in FIGS.14 through 17A, with the outlet port of the device closed as, forexample, by a clamped delivery tube, reservoir 84 can be filled byremoving sterile safety cap 103 (FIG. 15) and inserting vial 99 intoopening 83e of chamber 83d of housing 83. As the vial, which has beenpreviously prefilled with the fluid to be dispensed, is urged inwardlyof chamber 83d, needle 102 will pierce pierceable plunger 100 in themanner shown in FIG. 17A. Continued inward movement of the vial willcause the plunger to engage an internal stem 83f which is formedinternally of chamber 83. Stem 83f will force plunger 100 inwardly ofthe vial from the position shown in the phantom lines of FIG. 17A to theposition shown in the solid lines. This telescopic movement of plunger100 will cause the fluid contained within reservoir 99c to be forcedinto the internal fluid passageway 102a of hollow needle 102. As bestseen in FIG. 15, passageway 102a of the needle communicates withpassageway 105 formed in stem 83f and then into a transverse passageway105a formed internally of housing 83. Passageway 105a is, in turn, incommunication with reservoir 84 so that fluid flowing from vial 99 willflow into and fill reservoir 84.

As the fluid under pressure flows into reservoir 84, it will engage apiston-like member 95 which will, in turn, compress stored energy member94 in the manner shown in FIG. 17A. When vial 99 is fully seated withinchamber 83d, a cooperating split ring 103a (FIG. 15) will securely lockthe vial in place within chamber 83d in the manner shown in FIG. 17a.

Upon opening the clamped fluid delivery tube, the stored energy means ormember 94, will tend to return to its uncompressed startingconfiguration thereby controllably urging piston 95 to movetelescopically within reservoir 84 this telescopic movement of piston 95will cause the fluid contained in the reservoir to flow outwardly of thedevice via rate control element 88 and filter element 89. Fluid flowingthrough these elements will flow into an annular shaped fluid passageway107 formed in cap assembly 86 and then outwardly of the device viaoutlet port 92.

Turning once again to FIGS. 14 and 15, it is to be observed that bodyportion 83b of the housing is provided with a transparent indiciacarrying portion 108 which comprises a part of the indicator means ofthe invention for indicating the amount of fluid contained withinreservoir 84. Since reservoir 84 is visible through cover portion 108,the location of member 95 within reservoir 84 can be observed inrelation to the indicia 108a provided on portion 108. In this way, atany point in time, the amount of fluid remaining within the reservoircan be readily ascertained.

An alternate filling and drug recovery means for either fillingreservoir 84 or for recovering drugs therefrom is also here provided.This alternate means comprises a septum assembly 109 which is carriedwithin a septum receiving chamber 109a provided in the side wall ofcover 83b (FIGS. 14 and 15). Chamber 109a is in communication withpassageway 105a of housing 83b so that fluid under pressure introducedinto passageway 105a through the use of a syringe, the needle of whichhas pierced septum 109b of the septum assembly, will flow under pressureinto reservoir 84. As before, this fluid flowing into reservoir 84 willimpinge upon piston 95 moving it telescopically inwardly of thereservoir and controllably compressing the stored energy member 94.After being thusly compressed, the stored energy member can function tocontrollably expel fluid from the device during the delivery step. Insimilar fashion, drugs can be removed from the reservoir using a syringeand thereby recovered if desired. As shown in FIG. 15, septum 109b isretained within chamber 109a by a retaining cap 109c which isappropriately bonded to cover 83b (FIG. 17A).

Comprising a part of the housing assembly is means for affixing thedevice to the patient. This means here comprises a sponge pad 110 havingadhesive covered surfaces 110a and 110b (FIG. 14). Pad 110 is receivablewithin an opening 111 formed in base 83a so that the adhesive coveredsponge can bond the cover assembly to base 83 and also bond theassemblage to the patient.

The housing assembly itself can be constructed from various materialsincluding polycarbonate, acrylic, polystyrene and the like. Vial 99 ispreferably constructed from glass or suitable plastic materials. Plunger100 can be constructed from appropriate elastomers such as rubber orsilicon.

Needle 102a is preferably made from stainless steel and may be a sharpor blunt end cannula.

Referring next to FIGS. 18 through 33, still another embodiment of themedicament delivery system of the present invention is there illustratedand generally designated by the numeral 112. The apparatus of this formof the invention comprises an elongated body 114, which is made up ofthree interconnected, generally tubular shaped portions 116, 118, and120 respectively, portion 120 comprises a part of the operating means ofthe invention, the purpose of which will presently be described. As bestseen by referring to FIG. 23, when portions 116, 118, and 120 areinterconnected to form elongated body 114 they define first, second andthird communicating interior chambers 122, 124, and 126 respectively.

Removably receivable within a top opening 122a of first chamber 122(FIG. 21) is a prefilled medicament vial 130 having a first end 130asealed by a pierceable member 132 and a second end 130b sealed by anelastomeric plunger 134 which is telescopically movable longitudinallyof the internal fluid reservoir or chamber 130c of vial 130. Pierceablemember 132 comprises a part of the outlet means of the reservoir forpermitting fluid flow therefrom.

Disposed within second chamber 124 of elongated body 114 is plungerengaging means for moving plunger 134 of the vial assembly axially ofchamber 130c. The details of construction and operation of this plungerengaging means and its interrelationship with the operating means willpresently be described. Also disposed within second chamber 124 of theelongated body is the novel stored energy means of the invention, whichprovides energy necessary to move plunger 134 longitudinally ofreservoir 130c. This unique stored energy means here comprises acontrollably stretchable elastomeric, dome-like member 137 which isstretchable from a first configuration shown in FIG. 23 to a second,stretched configuration shown in FIG. 33 wherein it has a tendency toreturn toward its first configuration. The method and apparatus forcontrollably stretching elastomeric member 137, which includes member120 and its finger-engaging portion 120a (FIG. 18), will be described inthe paragraphs which follow.

Also comprising an important aspect of the apparatus of the present formof the invention is flow control means for controlling the outward flowof fluid flowing from the reservoir or internal chamber 130c of vial130. This flow control means here comprises a body portion provided inthe form of an end cap assembly 140 which is threadably interconnectablewith body portion 116. As best seen by referring to FIG. 21, capassembly 140 comprises an internally threaded cap 142 having a fluidoutlet 144 and defining an interior chamber 146. Disposed within chamber146 and forming a part of the flow control means of the invention is acannula assembly 148 which comprises a hollow cannula 150 and a cannulasupport plate 152. Cannula 150 can be either a conventional, sharp,hollow needle or a blunt end cannula of a character well known in theart. Cannula assembly 148 is held in position within cap 142 by sonicbonding or the like. Disposed adjacent plate 152 is a spacer means,shown here as a compressible, elastomeric spacer plug assembly 154,which includes a pierceable membrane 154a that is receivable within themouth of cap chamber 146 in the manner shown in FIG. 23. Prior to thecap assembly being interconnected with body portion 116 interior chamber146 of the cap assembly is preferably closed and maintained in a sterileconfiguration by a tear-away cap of construction well known to thoseskilled in the art.

Disposed between cannula support plate 152 and an end wall 142a of cap142 (FIG. 23) is a filtering and flow rate control means for filteringand controlling the rate of fluid flow outwardly through outlet 144 ofcap 142. This filtering and fluid rate control means comprises a part ofthe fluid flow control means of the invention and, in the form of theinvention shown in the drawings, includes a rate control filter 161.Rate control 161, which can be constructed from any suitable porousmaterial such as a polycarbonate, a metal or a ceramic, is supported bya support plate 163 carried within chamber 146. In some instances,additional filtration is desired upstream of rate control element 161and in those instances a porous filter is placed upstream of element161. This filter can be of the character shown in FIG. 15 and designatedby the numeral 89. Support plate 163 can be constructed from anysuitable porous material of a character well known by those skilled inthe art as, by way of example, porous polypropylene, porouspolycarbonate, and porous polysulfone and non-porous polyamide soldunder the name and style KAPTON.

In using the apparatus of the invention shown in FIGS. 18 through 30 thecomponent parts of the apparatus are assembled in the manner shown inFIG. 23. More particularly, fluid vial 130 containing a fluid such asthe medicament "M", which may be insulin, antibiotics, analgesics,oncolytics, human growth hormones, genetically engineered biologicagents, or any other type of injectable beneficial agent, is insertedinto first chamber 122 of the elongated body via top opening 122a. Endassembly 142 is then threadably interconnected with body portion 116.Next, the plunger engaging means shown here as an elongated pushermember 170 is inserted into second chamber 124 in the manner shown inFIG. 23. Connected to pusher member 170 is the novel stored energy meansof the invention which is shown here as elastomeric dome member 137.Dome member 137 includes a dome or top portion 137a, a flange 137b andside walls 137c which interconnect portions 137a and 137b. Flange 137bis clamped within a groove 138a formed in a ring 138 which is slidablydisposed within chamber 124 by a cylindrical portion 175 of theoperating means which also extends into chamber 124. In this regard, itis to be noted that body 120 is provided with internal threads 172 (FIG.23) which engage external threads 174 that are formed on portion 177 ofthe operating means which is connected to cylindrical portion 175.Portion 177 is initially disposed within chamber 126 so that as portion120 is rotated, it cooperates with threaded portion 177 to strategicallyadvance portion 175 inwardly of chamber 124 causing telescopic movementof ring 138 longitudinally of chamber 124.

After the apparatus has been assembled in the manner shown in FIG. 23, acylindrically shaped head portion 170a of pusher member 170 will engageportion 137a of elastomeric dome 137. Simultaneously, end 170b of thepush rod will engage plunger 134 of the vial assembly in the mannershown in FIG. 23. With this novel construction, and unlike the prior artdevices, the stored energy means never contacts the fluid to bedispensed thereby preserving the sterile integrity of the reservoircontents.

At the start of the operation of the apparatus of this latest form ofthe invention, locking means, shown here as a push button assembly 180,is in the unlocked configuration shown in FIG. 23. With the lockingmeans in this unlocked position, rotation of member 120 relative tomember 118 and relative to portion 177 will cause portion 177 to advancewithin chamber 124 from the starting position shown in FIG. 23 to theextended position shown in FIG. 33.

As best seen in FIGS. 21, 23, 24, and 33, portion 177 includes aplurality of longitudinally spaced splines 182 which, during operationof the device, are sequentially engaged by an interiorly extending tab183 (FIGS. 21 and 24) provided on a forwardly extending portion 198 ofmember 118. Splines 182 and tab 183 comprise the tactile sensing meansof the invention for providing a tactile sensation as the stored energymeans is stretched. It is also to be noted that portion 198 includes abearing surface 118a upon which member 120 rotates.

As portion 177 of the operating means moves toward its advanced orextended position, it will urge travel of ring 138 over pusher member170. However, when the outlet port of cap 140 is closed by closure 188in the manner shown in FIG. 23, fluid cannot flow outwardly of theoutlet port. Accordingly, when the outlet is closed, the resistanceoffered by the fluid within the vial reservoir to axial movement ofplunger 134 will cause the pusher member to controllably stretch wall137c of elastomeric dome 137 in the manner shown in FIG. 33. With thisconstruction, upon opening outlet 144, only then will a fluid flow pathbe formed between the medicament reservoir of the vial and an infusionset or other delivery system 190 which is connected to cap 142 in themanner shown in FIG. 34, thereby permitting fluid to be dispensed fromthe device. As before, expansion of the stored energy means provides theforce necessary to cause the controlled movement of the vial plunger andthe resulting discharge of the fluid contained within the vial. It is tobe noted that a novel feature of the operating means is that this meanspermits the stored energy means to be controllably expanded to anydesired strain energy density loading to enable precise solution offluid flow rates. Indicia "I" are provided on members 118 and 120 sothat the degree of loading of the stored energy means can be selected.

Following the desired strain energy density loading of the stored energymeans, portion 177 of the operating means can be locked in the extendedposition shown in FIG. 33 through operation of push button 192 of thelocking means or locking assembly 180 in a manner to push it inwardlyinto the open end of body portion 120. As best seen by referring toFIGS. 21 and 23, push button 192 includes an internal chamber 194 intowhich a generally cylindrically shaped extension 196 of portion 198 ofmember 118 extends. As best seen in FIG. 21, portion 198 comprises apair of spaced apart connector arms 198a and 198b which connect portions118a and 196.

Formed on extension 196 are circumferentially spaced, arcuate shapedretaining segments 200 (FIG. 21) which are lockably engageable with afirst annular collar 202 formed within chamber 194. Also formed withinchamber 194 is a second annular collar 204 which is engageable byarcuate retaining segments 200 when push button 192 is pushed inwardlyof body portion 120 (FIG. 33). To guide travel of push button 192inwardly of body portion 120 and to lock the finger-engaging meansagainst rotation with respect to member 118, the push button is providedwith a keyway 206 (FIGS. 21 and 23) which slidably receives a key 208formed within interior chamber 126 of body portion 120. Also forming apart of the locking means of this form of the invention, is anon-rotatable locking ring 210 which is affixed to extension 196 as bysonic bonding. As indicated in FIG. 21, ring 210 is provided withcircumferentially extending teeth 210a which lockably engage serations212 provided within push button 192 when the push button is fullyinserted as shown in FIG. 33. Because key 208 is locked within keyway206, rotation of the push button relative to the member 120 isprevented. Therefore, when the push button is locked against rotationwith respect to fixed ring 210, rotation of member 120 is alsopositively prevented.

During the fluid delivery step, the stored energy source or stretchedelastomeric dome member 137, will move pusher member 170 toward itsinitial starting configuration. This causes vial 130 to move from theposition shown in FIG. 23 to the position shown in FIG. 33 whereincannula 150 pierces member 154a and septum 132 thereby opening a flowpath between reservoir 130c and the fluid delivery means. The storedenergy source will then cause plunger 134 to move axially of reservoir130c from a first position shown in FIG. 23 to a second position shownin FIG. 34. As the plunger moves within the reservoir, the fluidcontained therein will be urged into the fluid passageway 150 of cannula150 and toward the flow control means of the apparatus (FIG. 34). Thefluid will then flow under pressure through rate control 161 and thenoutwardly of outlet 144 and into the fluid delivery means 190.

The various fluids that can be dispensed from vial 130c, include allthose previously described, including by way of example, beneficialagents, such as medicaments of various types, drugs and pharmaceuticals.

With respect to the important stored energy means, as before a widevariety of materials such as those previously described, can be used toform the stored energy means including synthetic polymers, latex rubber,synthetic rubber, rubber polyolefins, silicon plastics and otherthermoplastic elastomers (TPE) and thermoplastic urethane (TPU).

Manufactures of materials suitable for use in the construction of storedenergy source, include Advance Elastomer Systems, Dow Chemical, GeneralElectric, B.P. Polymers, Mobay Chemical, Shell Oil Corp., PetrarchSystems, DuPont, Akron Rubber, Concept Polymers and Union Carbide.

Turning particularly to FIGS. 21, 31, and 32 cap 142 is provided withthreads 142t which threadably engage threads 116t provided on bodyportion 116. Cap 142 is also provided with circumferentially extending,flexibly deformable locking tabs 143 which are adapted to lockablyengage locking teeth 116a provided on body portion 116. When the lockingtabs 143 engage locking teeth 116a in the manner shown in FIG. 32,removal of the cap is effectively prevented.

Turning next to FIGS. 18, 21, 22, and 29, the embodiment of theinvention there shown comprises a support means for removably supportingbody 114. This support means here includes a supporting base assembly214, which is designed to be lockably interconnected with and securelysupport elongated body 118 in the manner shown in FIG. 18. As best seenin FIG. 21, base assembly 214 includes a curved base plate 216 which isprovided with longitudinally extending channel 218 and a lockingassembly 220 which includes a transversely extending release arm 222having a locking protuberance 224. Locking protuberance 224 is providedwith a sloping face that is adapted to engage one of a plurality ofoutwardly extending locking teeth 226 (FIG. 23) provided on the base ofbody member 118 as flange portion 118b of member 118 is slidablyreceived within groove 218.

With this construction, as flange 118b slides into groove 218protuberance 224 will ratchet over teeth 226 until body portion 118 isfinally seated within the base assembly. At this point, the engagedtooth will block removal of flange 118b. However, upon depressing arm222, protuberance 224 will pivot downwardly about leg 225 (FIG. 21) ofthe release mechanism so as to move clear of the teeth so that bodyportion 118 can be disengaged from the base assembly.

Body 114 can be interconnected with other types of base assemblies whichpermit the interconnection therewith of a variety of fastening devicesthat enable the apparatus to be readily interconnected with the body orclothing of an ambulatory patient.

Materials particularly well suited for the construction of the elongatedbody and the operating member include polycarbonates, nylons, andacrylics. Preferred materials for the construction of thepusher-engaging member include polypropylene, polystyrene and polyoxnylchloride.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

I claim:
 1. A dispensing apparatus for dispensing fluids comprising:(a)a housing having first and second chambers, said first chamber includinga fluid reservoir having an outlet for permitting fluid flow from saidfluid reservoir; (b) stored energy means for acting upon the fluidcontained within said reservoir to cause the fluid to controllably flowthrough said outlet, said stored energy means comprising a compressivelydeformable, elastomeric member carried within said reservoir, saidelastomeric member being expandable to cause fluid flow from saidreservoir; (c) fill means for filling said reservoir with the fluid tobe dispensed, said fill means comprising a fill vial assembly receivablewithin said second chamber of said housing; and (d) dispensing means fordispensing fluid from said fluid reservoir, said dispensing meanscomprising a cap assembly connected to housing proximate said firstchamber, said cap assembly including a hollow cap having a fluid outletin communication with said outlet of said reservoir.
 2. An apparatus asdefined in claim 1 in which said elastomeric member comprises a flexiblepolymeric foam member.
 3. An apparatus as defined in claim 1 furtherincluding flow control means carried by said hollow cap for controllingfluid flow between said reservoir and said fluid outlet of said hollowcap.
 4. An apparatus defined in claim 1 in which said housing includesindicator means for indicating the amount of fluid contained within saidfluid reservoir thereof.
 5. An apparatus as defined in claim 1 in whichsaid housing includes a fluid passageway and in which said fill meansfurther comprises an elongated hollow needle disposed within said secondchamber, said hollow needle defining a flow passageway in communicationwith said fluid passageway of said housing.
 6. An apparatus as definedin claim 5 in which said fill vial assembly comprises:(a) a vial havinga first open end, a closed second end and a fluid reservoir disposedbetween said first and second ends; and (b) a pierceable plungerdisposed within said vial for movement within said fluid reservoir froma first to a second position.
 7. An apparatus as defined in claim 5 inwhich said housing includes a septum receiving chamber in communicationwith said fluid passageway and a pierceable septum mounted within saidseptum receiving chamber for gaining access to said fluid passageway.